The connection between prediabetes, diabetes, and risk of hepatocellular carcinoma (HCC) in HBsAg and anti-HCV seronegative patients, as well as the association between fasting glucose and HCC were examined in this study.

Original New Drug Application Approvals by US FDA (16 - 30 June 2017)

01 Aug 2017

New drug applications approved by US FDA as of 16 - 30 June 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

COTEMPLA XR-ODT

Active Ingredient(s): METHYLPHENIDATE

Strength: 8.6MG; 17.3MG; 25.9MG

Dosage Form: Disintegrating Extended-Release Oral Tablet

Company: Neos Theraps Inc

Approval Date: June 19, 2017

Chemical Type: Type 3 - New Dosage Form

Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age

Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy

Indication(s): Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE

The connection between prediabetes, diabetes, and risk of hepatocellular carcinoma (HCC) in HBsAg and anti-HCV seronegative patients, as well as the association between fasting glucose and HCC were examined in this study.